HRP20210839T1 - Pegilirani rekombinantni spojevi ljudskog hormona rasta - Google Patents
Pegilirani rekombinantni spojevi ljudskog hormona rasta Download PDFInfo
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- HRP20210839T1 HRP20210839T1 HRP20210839TT HRP20210839T HRP20210839T1 HR P20210839 T1 HRP20210839 T1 HR P20210839T1 HR P20210839T T HRP20210839T T HR P20210839TT HR P20210839 T HRP20210839 T HR P20210839T HR P20210839 T1 HRP20210839 T1 HR P20210839T1
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- 102000002265 Human Growth Hormone Human genes 0.000 title claims 5
- 108010000521 Human Growth Hormone Proteins 0.000 title claims 5
- 239000000854 Human Growth Hormone Substances 0.000 title claims 5
- 150000001875 compounds Chemical class 0.000 title 1
- 238000002360 preparation method Methods 0.000 claims 7
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 claims 6
- 125000000484 butyl group Chemical group [H]C([*])([H])C([H])([H])C([H])([H])C([H])([H])[H] 0.000 claims 4
- 208000035475 disorder Diseases 0.000 claims 4
- 229910052739 hydrogen Inorganic materials 0.000 claims 4
- 239000001257 hydrogen Substances 0.000 claims 4
- 206010056438 Growth hormone deficiency Diseases 0.000 claims 3
- 208000020221 Short stature Diseases 0.000 claims 3
- 208000031886 HIV Infections Diseases 0.000 claims 2
- 208000037357 HIV infectious disease Diseases 0.000 claims 2
- 208000005968 HIV-Associated Lipodystrophy Syndrome Diseases 0.000 claims 2
- UFHFLCQGNIYNRP-UHFFFAOYSA-N Hydrogen Chemical compound [H][H] UFHFLCQGNIYNRP-UHFFFAOYSA-N 0.000 claims 2
- 208000001132 Osteoporosis Diseases 0.000 claims 2
- 206010041092 Small for dates baby Diseases 0.000 claims 2
- 208000026928 Turner syndrome Diseases 0.000 claims 2
- 230000003712 anti-aging effect Effects 0.000 claims 2
- 230000001684 chronic effect Effects 0.000 claims 2
- 208000020832 chronic kidney disease Diseases 0.000 claims 2
- 238000003776 cleavage reaction Methods 0.000 claims 2
- 238000000502 dialysis Methods 0.000 claims 2
- 201000010099 disease Diseases 0.000 claims 2
- 125000001495 ethyl group Chemical group [H]C([H])([H])C([H])([H])* 0.000 claims 2
- 239000003862 glucocorticoid Substances 0.000 claims 2
- 208000033519 human immunodeficiency virus infectious disease Diseases 0.000 claims 2
- 125000004435 hydrogen atom Chemical class [H]* 0.000 claims 2
- 125000000959 isobutyl group Chemical group [H]C([H])([H])C([H])(C([H])([H])[H])C([H])([H])* 0.000 claims 2
- 125000001449 isopropyl group Chemical group [H]C([H])([H])C([H])(*)C([H])([H])[H] 0.000 claims 2
- 208000018773 low birth weight Diseases 0.000 claims 2
- 231100000533 low birth weight Toxicity 0.000 claims 2
- 125000002496 methyl group Chemical group [H]C([H])([H])* 0.000 claims 2
- 239000000825 pharmaceutical preparation Substances 0.000 claims 2
- 125000002924 primary amino group Chemical group [H]N([H])* 0.000 claims 2
- 125000001436 propyl group Chemical group [H]C([*])([H])C([H])([H])C([H])([H])[H] 0.000 claims 2
- 208000030507 AIDS Diseases 0.000 claims 1
- 208000002618 Aarskog syndrome Diseases 0.000 claims 1
- 208000033745 Aarskog-Scott syndrome Diseases 0.000 claims 1
- 208000004611 Abdominal Obesity Diseases 0.000 claims 1
- 208000010392 Bone Fractures Diseases 0.000 claims 1
- 206010006895 Cachexia Diseases 0.000 claims 1
- KXDHJXZQYSOELW-UHFFFAOYSA-M Carbamate Chemical compound NC([O-])=O KXDHJXZQYSOELW-UHFFFAOYSA-M 0.000 claims 1
- 208000024172 Cardiovascular disease Diseases 0.000 claims 1
- 206010007710 Cartilage injury Diseases 0.000 claims 1
- 206010065941 Central obesity Diseases 0.000 claims 1
- 206010008723 Chondrodystrophy Diseases 0.000 claims 1
- 208000006545 Chronic Obstructive Pulmonary Disease Diseases 0.000 claims 1
- 208000011231 Crohn disease Diseases 0.000 claims 1
- 201000003883 Cystic fibrosis Diseases 0.000 claims 1
- 201000010374 Down Syndrome Diseases 0.000 claims 1
- 208000010228 Erectile Dysfunction Diseases 0.000 claims 1
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 claims 1
- 208000001640 Fibromyalgia Diseases 0.000 claims 1
- 208000036119 Frailty Diseases 0.000 claims 1
- 206010064571 Gene mutation Diseases 0.000 claims 1
- 206010053759 Growth retardation Diseases 0.000 claims 1
- 206010019670 Hepatic function abnormal Diseases 0.000 claims 1
- 108700005087 Homeobox Genes Proteins 0.000 claims 1
- 208000003456 Juvenile Arthritis Diseases 0.000 claims 1
- 206010059176 Juvenile idiopathic arthritis Diseases 0.000 claims 1
- 208000007466 Male Infertility Diseases 0.000 claims 1
- 208000002720 Malnutrition Diseases 0.000 claims 1
- 208000026139 Memory disease Diseases 0.000 claims 1
- 208000001145 Metabolic Syndrome Diseases 0.000 claims 1
- 208000021642 Muscular disease Diseases 0.000 claims 1
- 201000009623 Myopathy Diseases 0.000 claims 1
- 206010028980 Neoplasm Diseases 0.000 claims 1
- 206010029748 Noonan syndrome Diseases 0.000 claims 1
- 201000010769 Prader-Willi syndrome Diseases 0.000 claims 1
- 206010049416 Short-bowel syndrome Diseases 0.000 claims 1
- 206010072610 Skeletal dysplasia Diseases 0.000 claims 1
- 208000032851 Subarachnoid Hemorrhage Diseases 0.000 claims 1
- 208000030886 Traumatic Brain injury Diseases 0.000 claims 1
- 208000027418 Wounds and injury Diseases 0.000 claims 1
- 201000000690 abdominal obesity-metabolic syndrome Diseases 0.000 claims 1
- 208000008919 achondroplasia Diseases 0.000 claims 1
- 230000032683 aging Effects 0.000 claims 1
- 125000002947 alkylene group Chemical group 0.000 claims 1
- 230000000735 allogeneic effect Effects 0.000 claims 1
- 125000003368 amide group Chemical group 0.000 claims 1
- 206010003246 arthritis Diseases 0.000 claims 1
- 206010003549 asthenia Diseases 0.000 claims 1
- 125000004429 atom Chemical group 0.000 claims 1
- 210000000988 bone and bone Anatomy 0.000 claims 1
- 201000011510 cancer Diseases 0.000 claims 1
- 125000004432 carbon atom Chemical group C* 0.000 claims 1
- 210000000845 cartilage Anatomy 0.000 claims 1
- 208000019069 chronic childhood arthritis Diseases 0.000 claims 1
- 208000022831 chronic renal failure syndrome Diseases 0.000 claims 1
- 125000004122 cyclic group Chemical group 0.000 claims 1
- 230000006378 damage Effects 0.000 claims 1
- 230000007850 degeneration Effects 0.000 claims 1
- 238000001784 detoxification Methods 0.000 claims 1
- 239000003814 drug Substances 0.000 claims 1
- 229940079593 drug Drugs 0.000 claims 1
- 238000002283 elective surgery Methods 0.000 claims 1
- 208000012043 faciodigitogenital syndrome Diseases 0.000 claims 1
- 125000000524 functional group Chemical group 0.000 claims 1
- 230000004927 fusion Effects 0.000 claims 1
- 125000005842 heteroatom Chemical group 0.000 claims 1
- 125000000623 heterocyclic group Chemical group 0.000 claims 1
- 201000010072 hypochondroplasia Diseases 0.000 claims 1
- 238000002513 implantation Methods 0.000 claims 1
- 201000001881 impotence Diseases 0.000 claims 1
- 208000014674 injury Diseases 0.000 claims 1
- 238000007918 intramuscular administration Methods 0.000 claims 1
- 238000001990 intravenous administration Methods 0.000 claims 1
- 201000002215 juvenile rheumatoid arthritis Diseases 0.000 claims 1
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- 210000003041 ligament Anatomy 0.000 claims 1
- 208000019423 liver disease Diseases 0.000 claims 1
- 230000001071 malnutrition Effects 0.000 claims 1
- 235000000824 malnutrition Nutrition 0.000 claims 1
- 239000000463 material Substances 0.000 claims 1
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- 229940127240 opiate Drugs 0.000 claims 1
- 230000011164 ossification Effects 0.000 claims 1
- 201000008482 osteoarthritis Diseases 0.000 claims 1
- 230000001097 osteosynthetic effect Effects 0.000 claims 1
- 239000008194 pharmaceutical composition Substances 0.000 claims 1
- 239000000546 pharmaceutical excipient Substances 0.000 claims 1
- 229940124531 pharmaceutical excipient Drugs 0.000 claims 1
- 239000000651 prodrug Substances 0.000 claims 1
- 229940002612 prodrug Drugs 0.000 claims 1
- 230000002035 prolonged effect Effects 0.000 claims 1
- 230000002441 reversible effect Effects 0.000 claims 1
- 206010039073 rheumatoid arthritis Diseases 0.000 claims 1
- 150000003431 steroids Chemical class 0.000 claims 1
- 238000007920 subcutaneous administration Methods 0.000 claims 1
- 238000001356 surgical procedure Methods 0.000 claims 1
- 208000011580 syndromic disease Diseases 0.000 claims 1
- 210000002435 tendon Anatomy 0.000 claims 1
- 230000009529 traumatic brain injury Effects 0.000 claims 1
- 230000000472 traumatic effect Effects 0.000 claims 1
Classifications
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- A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
- A61K38/22—Hormones
- A61K38/27—Growth hormone [GH] (Somatotropin)
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- C—CHEMISTRY; METALLURGY
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- C07K—PEPTIDES
- C07K14/00—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
- C07K14/435—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
- C07K14/575—Hormones
- C07K14/61—Growth hormones [GH] (Somatotropin)
Claims (9)
1. Farmaceutski pripravak, naznačen time, da sadrži prikladna farmaceutska pomoćna sredstva i također sadrži predlijek konjugat ljudskog hormona rasta (hGH) predstavljen formulom (AA):
hGH-NH-La-S0 (AA)
u kojoj
hGH-NH predstavlja hGH ostatak konjugiran s jednim od njegovih primarnih aminoskupina na La;
La predstavlja funkcionalnu skupinu koja se može sama hidrolizirati (samocijepati) putem skupine Ga koja inducira samocijepanje; i
S0 ima formulu (AAA1)
[image]
u kojoj
S00 je CH2; ili C(O);
S0A je alkilenski lanac s jednim do 20 atoma ugljika, koji je opcionalno prekinut ili završava s jednom ili više skupina, cikličkih struktura ili heteroatoma odabranih iz skupine koja se sastoji od opcionalno supstituiranog heterocikla; O; S; C(O); i NH;
BS1, BS2, BS3 se neovisno biraju iz skupine koja se sastoji od N; i CH;
S0C, S1B su (C(O)n2(CH2)n1(OCH2CH2)nOCH3, gdje je svaki n neovisno cijeli broj od 100 do 500, svaki n1 je neovisno 0, 1, 2, 3, 4, 5, 6, 7 ili 8, i n2 je 0 ili 1;
S2, S3 su neovisno vodik; ili (C(O)n2(CH2)n1(OCH2CH2)nOCH3, gdje je svaki n neovisno cijeli broj od 100 do 500, svaki n1 je neovisno 0, 1, 2, 3, 4, 5, 6, 7 ili 8, i n2 je 0 ili 1; uz uvjet da je najmanje jedan od S2, S3 različit od vodika; i
R2, R3 se neovisno biraju iz skupine koja se sastoji od vodika, metila, etila, propila, izopropila, butila, izobutila i tercijarnog butila.
2. Pripravak prema patentnom zahtjevu 1, naznačen time, da se La bira iz skupine koja se sastoji od -C(O)-O, i -C(O)-, koja zajedno s primarnom aminoskupinom od hGH tvori karbamat ili amidnu skupinu.
3. Pripravak prema patentnom zahtjevu 1 ili 2, naznačen time, da konjugat ima formulu (AA1)
hGH-NH-C(O)O-S0 (AA1).
4. Pripravak prema bilo kojem od patentnih zahtjeva 1 do 3, naznačen time, da Ga jest OC(O)-R i R ima formulu I
[image]
gdje se R1, R4, R5 neovisno biraju iz skupine koja se sastoji od vodika, metila, etila, propila, izopropila, butila, izobutila i tercijarnog butila; i
n je 1 ili 2.
5. Pripravak prema patentnom zahtjevu 4, naznačen time, da se R bira iz skupine koja se sastoji od
[image]
[image]
6. Pripravak prema bilo kojem od patentnih zahtjeva 1 do 5, naznačen time, da je najkraća udaljenost između mjesta vezanja za S0 na La i prve razgranate strukture BS1, koja se mjeri kao spojeni atomi, manja od 10.
7. Pripravak prema bilo kojem od patentnih zahtjeva 1 do 6, naznačen time, da farmaceutski pripravak jest pripravak za supkutanu primjenu, intramuskularnu primjenu ili intravenoznu primjenu.
8. Predlijek, naznačen time, da je definiran prema bilo kojem od patentnih zahtjeva 1 do 7.
9. Klinički učinkovita količina farmaceutskog pripravka u skladu s bilo kojim od patentnih zahtjeva 1 do 7, naznačena time, da je za uporabu u postupku liječenja bolesti koja se odnosi na GH kod ljudske osobe, pri čemu se bolest koja se odnosi na GH bira iz skupine koja se sastoji od sljedećih: deficijencija hormona rasta; napad deficijencije hormona rasta kod odraslih; Turnerov sindrom; Prader-Willijev sindrom; sindrom kratkih crijeva; kronična bubrežna insuficijencija; djeca premalena za gestacijsku dob (SGA – engl. small for gestational age); iscrpljenost zbog AIDS-a; protiv starenja (engl. anti-aging); reumatoidni artritis; homeobox-genske mutacije za niski rast; somatopauza; Noonanov sindrom; skeletna displazija; Downov sindrom; kratki rast povezan s produljenom uporabom steroida; Aarskogov sindrom; kronična bubrežna bolest; mladenački reumatoidni artritis; cistična fibroza; HIV-infekcija kod djece zbog primanja liječenja HAART; kratki rast kod djece rođene s vrlo niskom porođajnom težinom, osim SGA; hipohondroplazija; ahondroplazija; idiopatski kratki stas; deficijencija hormona rasta kod odraslih; frakture dugih kostiju ili frakture u njima; frakture spužvastog koštanog tkiva ili frakture u njemu; pacijenti nakon operacije tetiva ili ligamenata; distrakcijska osteogeneza; poremećaji kao rezultat zamjene kuka ili diska, popravka meniska, fuzije kralježnice ili fiksiranja proteze; poremećaji kao rezultat fiksiranja osteosintetskog materijala; nesrastanje ili pogrešno srastanje fraktura; poremećaji kao rezultat osteotomije; poremećaji kao rezultat alogene implantacije; degeneracija hrskavice koljenskog zgloba prouzročena ozljedom ili artritisom; osteoporoza kod pacijenata s Turnerovim sindromom; osteoporoza kod muškaraca; odrasli pacijenti na kroničnoj dijalizi (APCD – engl. adult patients in chronic dialysis); kardiovaskularne bolesti kod APCD, povezane s malnutricijom; povratna kaheksija kod APCD; rak kod APCD; kronična opstrukcijska plućna bolest kod APCD; HIV kod APCD; stariji ljudi kao APCD; kronična bolest jetre kod APCD; sindrom zamora kod APCD; Crohnova bolest; oslabljena funkcija jetre; muškarci s HIV infekcijom; centralna pretilost; lipodistrofijski sindrom povezan s HIV-om (HALS – engl. HIV-associated lypodistrophy syndrome); muška neplodnost; pacijenti nakon velike elektivne kirurške operacije, akoholne ili opijatne detoksifikacije ili neurološke ozljede; starenje; krhkost kod starijih ljudi; osteoartritis; traumatska povreda hrskavice; erektilna disfunkcija; fibromialgija; poremećaji pamćenja; depresija; traumatska ozljeda mozga; subarahnoidalna hemoragija; veoma mala porođajna težina; metabolički sindrom; glukokortikoidna miopatija; i kratki rast uslijed glukokortikoidnog liječenja kod djece.
Applications Claiming Priority (4)
Application Number | Priority Date | Filing Date | Title |
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EP08155408A EP2113256A1 (en) | 2008-04-29 | 2008-04-29 | PEGylated rhGH compounds |
EP08162865 | 2008-08-22 | ||
EP08167289 | 2008-10-22 | ||
EP16156852.2A EP3050576B1 (en) | 2008-04-29 | 2009-04-29 | Pegylated recombinant human growth hormone compounds |
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HRP20210839T1 true HRP20210839T1 (hr) | 2021-08-20 |
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HRP20161040TT HRP20161040T1 (hr) | 2008-04-29 | 2016-08-17 | Pegilirani rekombinantni spojevi ljudskog hormona rasta |
HRP20210839TT HRP20210839T1 (hr) | 2008-04-29 | 2021-05-25 | Pegilirani rekombinantni spojevi ljudskog hormona rasta |
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HRP20161040TT HRP20161040T1 (hr) | 2008-04-29 | 2016-08-17 | Pegilirani rekombinantni spojevi ljudskog hormona rasta |
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US (4) | US9272048B2 (hr) |
EP (3) | EP3050576B1 (hr) |
JP (5) | JP6112766B2 (hr) |
CN (2) | CN102989001B (hr) |
BR (1) | BRPI0911780B1 (hr) |
CA (3) | CA3004716C (hr) |
CY (2) | CY1117882T1 (hr) |
DK (2) | DK3050576T3 (hr) |
ES (2) | ES2875426T3 (hr) |
HK (2) | HK1152239A1 (hr) |
HR (2) | HRP20161040T1 (hr) |
HU (2) | HUE054585T2 (hr) |
IL (2) | IL208833A (hr) |
LT (2) | LT3050576T (hr) |
MX (2) | MX2010011800A (hr) |
PL (2) | PL2279007T3 (hr) |
PT (2) | PT2279007T (hr) |
RU (1) | RU2689336C2 (hr) |
SI (2) | SI3050576T1 (hr) |
WO (1) | WO2009133137A2 (hr) |
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